Treating rare disorders with ketamine

PharmaTher Granted FDA Orphan Drug Designation for Ketamine to Treat Status Epilepticus

PharmaTher (PHRM) is developing a treatment for a rare, seizure-inducing disorder called Status Epilepticus using ketamine. This week, it was granted a designation that will save them millions of dollars in the process. 

It’s called an Orphan Drug Designation and it gives the company potential tax credits, grant eligibility, and marketing exclusivity, and waives a $2.4M New Drug Application fee. It’s designed to incentivize R&D of treatments for rare conditions.

PharmaTher previously received the designation for ketamine to treat ALS and complex regional pain syndrome too!

PharmaTher Inc.

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Is this why ketamine helps with depression?

Perception study may explain promising depression therapy

Our brains are constantly making predictions about the world around us based on learned associations – if we hear sirens, we expect to see an ambulance. 

A recent study by University of Wisconsin–Madison researchers found that ketamine blocks the chemical signals that allow us to make predictions.

Why is this beneficial?

Many disorders are rooted in poor predictions. For instance, patients with depression often predict that the worst case scenario is bound to happen. 

“Blocking the negative predictions that are prominent in depressed patients could be how ketamine helps,” explains the school’s psychology and neuroscience professor.

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Pasithea Therapeutics Announces Opening of Mental Health Clinic in Los Angeles and Broadens Focus Beyond Ketamine Treatments

Pasithea Therapeutics Announces Opening of Mental Health Clinic in Los Angeles and Broadens Focus Beyond Ketamine Treatments

In-person clinic will provide ketamine therapy and other novel mental health treatments, including repeated transcranial magnetic stimulation (“rTMS”)

MIAMI BEACH, Fla., Jan. 26, 2022 (GLOBE NEWSWIRE) — Pasithea Therapeutics Corp. (Nasdaq: KTTA) (“Pasithea” or the “Company”), a novel biotechnology company focused on the research and discovery of new and effective treatments for psychiatric and neurological disorders, today announced that its wholly owned subsidiary, Pasithea Clinics, will open a clinic in Los Angeles, California, to provide intravenous (“IV”) ketamine and other therapies to patients suffering from treatment-resistant mental health issues. The Company will continue offering in-home ketamine therapy through its Los Angeles area at-home mobile clinics.

“The opening of our first in-person clinic in the United States is a milestone for the Company. Certain novel approaches in psychiatry cannot be delivered at home, such as repetitive transcranial magnetic stimulation (“rTMS”). This physical clinic will allow us to expand our services beyond IV ketamine therapy and continue to address the important segment of patients who are suffering from treatment resistant mental health disorders. This is a step forward in creating a hybrid model for Pasithea, complementing our at-home services,” stated Dr. Tiago Reis Marques, CEO of Pasithea Therapeutics.

Repeated transcranial magnetic stimulation is a therapeutic brain-stimulation technique based on the principle of electromagnetic induction. First developed in 1985, rTMS has been studied as a treatment for depression, psychosis, anxiety, and other mental health conditions, and has shown particular efficacy with drug-resistant depressive disorders. In 2008, rTMS was approved for use by the U.S. Food and Drug Administration (“FDA”) as a treatment for major depression for patients who do not respond to at least one antidepressant medication. A typical plan consists of five treatments per week over the course of four to six weeks and is currently covered by insurance.

Ketamine is an FDA approved drug introduced to the medical community as an anesthetic more than 50 years ago. It has recently been repurposed for the treatment of psychiatric disorders using significantly lower doses than in anesthesia and is gaining ground as a promising treatment for mental health disorders. In certain psychiatric conditions, such as treatment-resistant depression (“TRD”) and post-traumatic stress disorder (“PTSD”), it has shown remarkable efficacy and a rapid and sustained effect. While the number of treatments suggested is decided on a case-by-case basis, a typical treatment plan consists of up to six infusions in the interval of two to three weeks.

About Pasithea Therapeutics Corp.

Pasithea Therapeutics Corporation is a U.S. biotechnology company focused on the research and discovery of new and effective treatments for psychiatric and neurological disorders. With an experienced team of experts in the fields of neuroscience and psychopharmacology, Pasithea is developing new molecular entities for the treatment of psychiatric and neurological disorders. Pasithea is also focused on addressing the needs of patients currently suffering with mental illness by providing access to IV ketamine infusions both in clinics and in-home settings.

Pasithea has raised $60 million through offerings with a current cash position of ≥ $52 million.

Forward Looking Statements

This press release contains statements that constitute “forward-looking statements.” Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the Company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including, without limitation, those set forth in the Company’s filings with the SEC. Thus, actual results could be materially different. The Company undertakes no obligation to update these statements whether as a result of new information, future events or otherwise, after the date of this release, except as required by law.

Pasithea Therapeutics Corp. Company Contact

Dr. Tiago Reis Marques
Chief Executive Officer
E: tiago@pasithea.com

Pasithea Therapeutics Corp. Investor Relations

Lisa M. Wilson
In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com 

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Source: Pasithea

Released January 26, 2022

Be an industry insider

How can DMT be improved to better treat addiction? How do our genetics influence our psychedelic experiences? How does ketamine change our brain wave patterns? Does music make psychedelic therapy more effective?

These are all questions that Entheon Biomedical (ENBI) is answering with ongoing clinical research. Learn what they’ve discovered so far and their next steps at our Mental Health Town Hall this February 3rd!

We’ll be joined by Entheon’s Founder and CEO, Scientific Advisor, and Communications Manager to discuss the company’s findings and the future of psychedelic therapy. Click here to register for free to get the inside scoop.

Survey Finds Majority of Affected Americans Approve of Psychedelics as an Alternative Treatment to Address Anxiety, Depression and PTSD

Survey Finds Majority of Affected Americans Approve of Psychedelics as an Alternative Treatment to Address Anxiety, Depression and PTSD

VANCOUVER, BRITISH COLUMBIA, Jan. 11, 2021 – A new survey conducted by The Harris Poll on behalf of Delic Holdings Corp (“Delic” or the “Company”) (CSE: DELC) (OTCQB: DELCF) (FRA: 6X0) (Original Source), a leader in new medicines and treatments for a modern world, reports that nearly two thirds of Americans who suffer from anxiety/depression/PTSD (65%) believe that psychedelic medicine (i.e. ketamine, psilocybin and MDMA) should be made available to patients with treatment-resistant anxiety, depression or PTSD. 

According to the survey, conducted online in December, 2021 among 953 U.S. adults who suffer from anxiety/depression/PTSD, nearly two-thirds (63%) of Americans who have used prescription medications to treat anxiety/depression/PTSD say that while the medication helped, they still experienced residual feelings of anxiety, depression or PTSD. Furthermore, 18% say that the medication did not improve their condition/made it worse.

“We are witnessing a silent crisis impacting people across the globe exacerbated by an ongoing pandemic, and the results of this survey should compel more medical professionals and lawmakers to support in-depth studies on the therapeutic benefits of psychedelic medicine,” said Matt Stang, co-founder and CEO of Delic. “This promising family of new medicines has the potential to be more effective than traditional medicines with minimal side effects, giving people their best selves back. Our country’s mental health crisis not only impacts public health, but also the economy–each year, untreated mental illness costs the U.S. up to $300 billion in lost productivity.”

According to the study, 83% of Americans experiencing anxiety, depression or PTSD would be open to pursuing alternative treatments proven to be more effective than prescription medication with fewer side effects. Among those who suffer from anxiety/depression/PTSD, many would be open to using the following substances which have been identified as potential alternative treatments for those seeking to address their mental health conditions:

  • Ketamine: 66% would be open to pursuing treatment using ketamine to treat anxiety, depression or PTSD if it was proven more effective than prescription medication with fewer side effects.
  • Psilocybin: 62% said they would be open to pursuing treatment using psilocybin prescribed by a physician to address their anxiety, depression or PTSD if it was proven more effective than prescription medication with fewer side effects.
  • MDMA: 56% would be open to pursuing treatment using MDMA prescribed by a physician to treat their anxiety, depression or PTSD if it was proven more effective than prescription medication with fewer side effects.

Survey Method

This survey was conducted online within the United States by The Harris Poll on behalf of Delic from December 6 – 8, 2021 among 2,037 adults ages 18 and older, among whom 953 suffer from anxiety/depression/PTSD. This online survey is not based on a probability sample and therefore no estimate of theoretical sampling error can be calculated. For complete survey methodology, including weighting variables and subgroup sample sizes, please contact delic@mattio.com.

About The Harris Poll

The Harris Poll is one of the longest running surveys in the U.S., tracking public opinion, motivations and social sentiment since 1963. It is now part of Harris Insights & Analytics, a global consulting and market research firm that strives to reveal the authentic values of modern society to inspire leaders to create a better tomorrow. We work with clients in three primary areas: building twenty first century corporate reputation, crafting brand strategy and performance tracking, and earning organic media through public relations research. Our mission is to provide insights and advisory to help leaders make the best decisions possible.

About Delic Corp

Delic is a leader in new medicines and treatments for a modern world, improving access to health benefits across the country and reframing the conversation on psychedelics. The company owns and operates an umbrella of related businesses, including the largest chain of psychedelic wellness clinics in the country, including Ketamine Infusion Centers and Ketamine Wellness Centers; the only licensed entity by Health Canada to exclusively focus on research and development of psilocybin vaporization technology, Delic Labs; the premier psychedelic wellness event, Meet Delic; and trusted media and e-commerce platforms Reality Sandwich and Delic Radio. Delic is backed by a team of industry and cannabis veterans and a diverse network, whose mission is to provide education, research, high-quality products, and effective treatment options to the masses.

The Canadian Securities Exchange has neither approved nor disapproved the contents of this news release and does not accept responsibility for the adequacy or accuracy of this release.

This news release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities ‎in the United States. The securities have not been and will not be registered ‎under the United States ‎Securities Act of 1933, as amended (the “U.S. Securities Act”), or any state ‎securities laws and may not be offered or ‎sold within the United States unless registered under the U.S. ‎Securities Act and applicable state securities laws or an ‎exemption from such registration is available.‎

Forward Looking Statements

This media advisory contains forward–looking statements and forward–looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward–looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as “plans”, ” expects” or, “proposed”, “is expected”, “intends”, “anticipates”, or “believes”, or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, would, or might occur or be achieved. More particularly and without limitation, this news release contains forward–looking statements and information concerning a national consumer survey conducted by The Harris Poll. Such forward-looking statements and information reflect management’s current beliefs and are based on assumptions made by and information currently available to the company with respect to the matter described in this new release. Forward-looking statements involve risks and uncertainties, which are based on current expectations as of the date of this release and subject to known and unknown risks and uncertainties that could cause actual results to differ materially from those exp “We are witnessing a silent crisis impacting people across the globe exacerbated by an ongoing pandemic, and the results of this survey should compel more medical professionals and lawmakers to support in-depth studies on the therapeutic benefits of psychedelic medicine,” said Matt Stang, co-founder and CEO of Delic ressed or implied by such statements. Additional information about these assumptions and risks and uncertainties is contained under “Risk Factors and Uncertainties” in the Company’s latest annual information form filed September 23, 2019, which is available under the Company’s SEDAR profile at www.sedar.com, and in other filings that the Company has made and may make with applicable securities authorities in the future. Forward-looking statements contained herein are made only as to the date of this press release and we undertake no obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. The Canadian Securities Exchange has not reviewed, approved or disapproved the content of this news release.

Slowing the progression of ALS

PharmaTher Announces FDA Approval of Investigational New Drug (IND) Application for Ketamine to Treat ALS

When diagnosed with ALS, patients are typically given 2 to 6 years to live and experience rapid decline in muscle function. Even after the ice bucket challenge took the internet by storm, a cure has yet to be found. 

Luckily, ketamine is showing potential to slow the progression of the disease to improve both the quality and length of patients’ lives.

In a mouse model of ALS, PharmaTher (PHRM) found that ketamine preserved muscle function and increased life expectancy if administered in the early stages of the disease. 

The company received FDA approval for a Phase II trial that will assess a biomarker of neurodegeneration, functional abilities, muscle strength, and depression scores among ALS patients undergoing ketamine treatments.

PharmaTher Inc.

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The quest to treat addiction

After his brother overdosed in 2019, Timothy Ko founded Entheon Biomedical (ENBI) on his quest to find a better treatment for addiction through psychedelic therapy.

The company is focused on advancing the DMT molecule to treat substance use disorders. It just submitted a regulatory package to an ethics committee for a human clinical trial on healthy smokers, which will be one of the most comprehensive studies of DMT ever.

Entheon has also begun recruiting patients with treatment-resistant depression for a ketamine therapy study, which will be conducted with Heading Health LLC. The study will use an electroencephalography (EEG) headset and genetic screening to:

  • Understand how ketamine influences brainwave patterns
  • Investigate how genetic markers influence ketamine response
  • Explore the effects of music on therapeutic outcomes
  • Develop a framework for characterizing the psychedelic drug state

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